Site Set Up

Protocol

V3.0 18.05.2023

Resource Summary

A handy contents page of all our resources in one place and how to use them can be downloaded here.


Local Information Pack 

[for sites in England, Wales & Northern Ireland]

The local information pack for T4P can be downloaded here.

 

Investigator Site File

For sites in England, Wales, Northern Ireland - the Investigator Site File for T4P can be downloaded here.

For sites in Scotland – the Investigator Site File for T4P can be downloaded here.

 

Site Working File

Working files for T4P can be downloaded here. These are optional for use but contain suggested materials for sites to create screening and randomisation files or ‘grab-packs’ for clinical staff undertaking these duties. The materials can be adapted for local use.

 

Training

Site Initiation Visits (SIVs)

We are now holding virtual SIVs (over Teams/Zoom). If you would like to attend an SIV, please contact the T4P trial team to arrange a suitable date (T4P@icnarc.org).

The latest SIV slides can be downloaded ⁠here

An SIV recording can be downloaded here NB. The most up to date information regarding person confirming eligibility can be found in the above SIV slides.

Screening and Randomisation Training

For staff who are undertaking screening and randomisation only for T4P, training slides are available to download here. These slides can be adapted for local use.

Randomisation Guide can be found here.

A CRF Guidance document can be found here which explains how to answer every question on MACRO.  There are also worksheets.

Certificates

Please see below certificates to give to staff for supporting T4P at your site, randomising patients, and completing trial training.

Certificate of Support

Certificate of Randomisation

Certificate of Training

Poster and Bedside Notices

We provide laminated bedside threshold notices and laminated posters. Please contact the T4P team if you would like to receive more laminated materials. These are also available to download below. 

Bedside Notices v1.0

T4P site poster V1.0

Bedside Teaching

Bedside Teaching Summary

Transfusion Team Factsheet (optional)

Transfusion Factsheet

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